REGULATORY AFFAIRS PROFESSIONALS SOCIETY HORIZONS CONFERENCE & EXHIBITION March 30, 2006 San Diego, California

1. Crisis Management& FDA-Regulated Firms REGULATORY AFFAIRS PROFESSIONALS SOCIETY HORIZONS CONFERENCE & EXHIBITION March 30, 2006 San Diego, California Michael A. Swit, Esq.Vice President, Life Sciences

2. Our Objectives Today • Key Crisis Management Tools Senior Regulatory Professionals Should Know • A Crisis History – the Generic Drug Scandal • Fundamentals of Crisis Management • Complexities of Disclosure and other Corporate Duties Owed By Regulatory Professionals • What Does Vioxx and Guidant Got To Do With It? … 2

3. Definition cri·sisEtymology: Middle English, from Latin, from Greek krisis, literally, decision, from krinein to decide 1 a: the turning point for better or worse in an acute disease or fever b: a paroxysmal attack of pain, distress, or disordered function c: an emotionally significant event or radical change of status in a person's life <a midlife crisis> 2: the decisive moment (as in a literary plot)3 a:an unstable or crucial time or state of affairs in which a decisive change is impending; especially : one with the distinct possibility of a highly undesirable outcome <a financial crisis> b: a situation that has reached a critical phase <the environmental crisis>source: Merriam-Webster Online Dictionary 3

4. A Crisis History -- the Generic Drug Scandal

5. 60 Seconds of History • 1984 – Hatch-Waxman Act passes – liberalizing generic drug approval process • Generic Industry’s Challenge – being first to approval for brand name drug • Upside – set price, size, shape & color; ensure market penetration • Downside – if not first, entering a commodity market; price drives & margins disappear 5

6. Then What Happened? • Mylan – thought it kept losing the race; reaction – hired a private eye; went through Charlie Chang’s trash • Result – • Congressional investigation -- July 1988 • Gratuity pleas/convictions • Industry – including a Par Senior VP • FDA Generic Drug officials 6

7. But, we’re not finished yet … • Maxzide Samples Switch – Par – announced just a few weeks after gratuity conviction – July 1989 • Why FDA asked for sample – tip from disgruntled fired employee • Immediate Consequences • another senior VP resigns in a cloud • Voluntary marketing moratorium of all drugs • New CEO – and other management team, including: VP/GC, VP/RA, VP/QA, VP/QC, VP/Ops, VP/R&D • Additional grand jury proceedings 7

8. How We Faced The Crisis? • Honest, Consistent and Balanced Disclosure to all stakeholders • Government • Business Partners • Public • Complete overhaul of corporation and operations • Senior Management and other personnel • Procedures • Training 8

9. How We Faced The Crisis … • Audits by outside experts • Code of conduct • Ethics training – access to outside board members • Cooperation with federal investigators • “Voluntary Declaration” – was the vehicle for expressing the cooperation 9

10. Immense Lost sales -- $102 mm in ’89 vs. $55 mm in ‘90 Laid off employees – 900 to 450 Criminal and civil fines -- $2.75 mm (high at that time) Shareholder litigation settlement -- $2.25 mm Stock went from $27 to < $3 per share Did not exceed $10 share again until ~ 1998 Outside auditors & attorneys fees -- ~$5 mm Interference with business operations – little R&D for four years -- incalculable Civil law suits -- ~ $13 million The Cost? 10

11. The Long-Term Result • Company survived – one of the few involved in the generic drug scandal • Public perception of generic industry tainted for years – only in past five years or so have generics turned the corner (partially due to the perceived “evils” of the branded industry) • Changed dynamics of dealing with FDA for the next decade and beyond 11

12. Crisis Management –Fundamentals of Crisis Management

13. Be Prepared • Have a written crisis management plan • But, understand, that the key “… is the philosophy of [the executive] management that steers a company through a crisis, not the plan of action on file.” • Larry Foster, VP Public Affairs of Johnson & Johnson during the Tylenol Tampering Crisis of 1982, writing in When Lightning Strikes, A How-To Crisis Manual with Classic Case Studies, Pines, Wayne L., Editor. Washington Business Information, Inc., 1994, p. 205. • Johnson & Johnson – focused on its Credo in making all decisions relating to Tylenol Tampering 13

14. The J&J Credo • We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services. In meeting their needs everything we do must be of high quality… • We are responsible to our employees, the men and women who work with us throughout the world…. • We are responsible to the communities in which we live and work and to the world community as well. We must be good citizens ... • Our final responsibility is to our stockholders. Business must make a sound profit…. Source: www.jnj.com/our_company/our_credo/index.htmWritten by General Robert Wood Johnson, 1943 14

15. Identify Your Corporate Philosophy in Facing a Crisis • At J&J -- the Credo already existed • Important to articulate before a crisis hits; because you can’t afford – but will need to -- to take the time later • The Philosophy will drive your crisis management goals, such as: • Public health protection • Minimizing adverse publicity • Cutting products liability and/or shareholder litigation risks • Reducing chances – or impact -- of governmental regulatory or legal – civil or criminal -- action 15

16. Identify Crisis Team in Advance • Head – senior member of management. If serious health hazard, CEO should be intimately involved and public face of company • Ensure all key functions within firm are represented, and at senior levels, such as: • Legal • PR • Regulatory Affairs • Medical/Scientific • Finance (may have SEC disclosure issues) • Other departments as specific to the crisis subject 16

17. Identify Crisis Team … • Outside Counsel • FDA • Criminal • SEC • Products Liability • Outside Consultants – pick with care for both what they know and who they know • PR -- e.g., former FDA Affairs staffers • Congressional – e.g., at Par, we used Patrick McLain, a former Dingell staffer as our liaison • Medical/Scientific – e.g., Guidant Independent Review Panel – used David Feigal, ex-head of Device Center at FDA • Toxicological • Epidemiological 17

18. Preparing the Team • Train Your Team • Handling the press and other public inquiries • Dealing with documents to ensure that all in company know how documents will be managed: • Attorney-client privilege and attorney work-product doctrine is maintained where appropriate • Consistency – controlling information flow within and without co. • Handling of drafts • Record retention • Mock Crises – once a year using outside experts to simulate • Revise the Plan based on the mock crises • Have documentation ready on company and products – easier today due to websites 18

19. Some Key Principles in Managing a Crisis • Obtain as much information as possible • Isolate the crisis team if needed • Communicate inside the company with care, but don’t let your employees find out from the outside • Centralize communication through the crisis team • Vette documents carefully – and through counsel • Document, but with care – avoid “bad” documents 19

20. Know Your Stakeholders • Consumers • General Public • Media • Management • Shareholders • Regulators • Congress • Public Interest Groups • Plaintiffs’ Attorneys • Prosecutors 20

21. Managing Publicity • Whenever possible, break the bad news yourselves • P&G – pulled the Rely Tampon in Sept. 1980 before FDA could take action • Centralized spokesperson – Tylenol – was Jim Burke, CEO of J&J • If a geographic focus to crisis – have CEO go there • Resist the temptation to tell too much (see Criminal Liability) • Be clear and careful in your message • Be honest • Distinguish fact vs. speculation • Don’t minimize the problem 21

22. Managing Publicity … • Inform Key Government Stakeholders before making disclosure • Challenge – but the district office wants to review my recall press release before I send it out • Rehearse, Rehearse, Rehearse • Know your press coverage (harder to do in this Internet age) • Remember, they are on deadline -- you have to have your “story” ready or they will write without yours • Have key lists ready • Customers in the route of distribution (and make sure they know who their customers are) • Doctors, pharmacists, public health officials 22

23. Managing Publicity … • Know What Your Company Has Planned – e.g., may need to cancel major ad campaign in event of a recall • Tylenol – they stopped all TV ads • Keep the lines of communication open • 800 #’s • Website frequently updated – and ensure info on the crisis is on your “HOME” page and easily found (you can then link through to more detail) • Tylenol – they even used sound trucks in Chicago • Keep feedback coming in from outside – J&J did consumer surveys in Tylenol Crisis to learn public view 23

24. Addressing Criminal Exposure • Difficult to balance desire to disclose and need to insulate the company from liability • Need to investigate internally – using counsel -- quickly to know what exposure is to decide: • To “roll over” and plea – cooperate • Defend to max • First hint – often is a subpoena for documents 24

25. Addressing Criminal Exposure … • Handling subpoenas • Custodian of documents – secures documents • Communicate to all employees on document retention – must ensure no chance of obstruction claims • Handling with officers & employees that may have exposure – very delicate – remember that company counsel is just that … the company’s • Do not discuss facts under investigation outside company 25

26. Crisis Management –Disclosure and Other Corporate Law Duties Owed By Regulatory Professionals at Publicly-Held Companies

27. Caveat • I am an FDA regulatory attorney, not an SEC lawyer • But, this could happen to you … • My first day as General Counsel of Par Pharmaceutical, a publicly-traded company, the CFO says to me, “we have this situation [can’t tell you what it was], do we need to disclose this? • Can’t tell you my answer either -- but there was no press release that day or for a number of days thereafter until we sufficiently completed an internal investigation 27

28. Duties • FDA-Regulated Firms • Lawfully market safe and effective products that are not adulterated or misbranded • U.S. v. Park – responsible corporate agents in a position to prevent a violation can be criminally liable for FDA violations event w/o intent or knowledge • Duty to seek out potential violations • No affirmative duty to publicly disclose “material” information • Affirmative duties to disclose to FDA • Field Alerts – 314.81 – mix-ups or specifications failures • Stability commitments 28

29. Duties … • SEC Regulated Firms • Very detailed disclosure requirements • But, absent an affirmative duty to disclose, silence is not misleading (except may have a duty to correct prior disclosures now learned to be wrong & if you want to trade, must disclose) • Question – when are there affirmative duties to disclose under SEC law? • Answer – focus is usually “materiality” of the event -- we will explore some examples later in the FDA context • No overt duty to investigate corporate problems; however, under SOX, now are multiple duties on a company to have adequate procedures to ensure accuracy of public reports • Stock Exchanges – NYSE ♦ NASDAQ • Have more affirmative duties to disclose – usually done via press release 29

30. Duties … • General Corporate Law – • No overt duty to disclose material information to public • Related duties impacting corporate responsibility • Delaware law – must have an adequate compliance program to prevent violations and probe to ensure violations did not occur – Caremark (1996) • McCall (2001): Columbia/HCA shareholder derivative action against board members; • Directors lose protection of “business judgment” rule and are personally liable for failure to detect and correct violations • Board’s duty of care breached through nonfeasance: failure to investigate items from internal audit 30

31. Timing Rules • FDA • Annual reports – INDs & NDAs • Field Alerts – 3 “working” days • Adverse Events – • Unexpected serious AE -- “as soon as possible,” but no later than 15 calendar days • Others – quarterly for first 3 years post-approval; then annually • SEC • Annual & quarterly reports – updates since prior • 8-K’s – for certain specified and “other events” – supposed to implement SOX "real time issuer disclosure" requirement – within 4 business days of the event 31

32. Codes of Ethics • SOX – for senior financial officers • NYSE & NASDAQ – for whole company • FDA • No duty to have a code • Exception – Application Integrity Program – then need one 32

33. Record Retention • SOX – 7 years • FDA – vary – but less than that typically • Caution – record retention beyond required may come back to both help you or haunt you – implement with care 33

34. Life Sciences Companies Disclosures and the SEC • For a disclosure to be actionable, it usually must be both false or misleading and “material” – thus, these are fact-specific scenarios • “Material” – info would have “actual significance in the deliberations of the reasonable shareholder” 34

35. Life Sciences Companies Disclosures and the SEC … • Forward Looking Statements – • Safe harbor • Must be a “meaningful cautionary” statement – and not omit any key information as well • Only liable if false statement made with actual knowledge of its falsity • Predicting FDA approval -- OK to be wrong as long as there was a reasonable basis for the initial prediction • But, contrast if those making the disclosure knew a key undisclosed fact that seriously threatened the predicted approval time • No clear duty to update 35

36. Life Sciences Companies Disclosures and the SEC … • Adverse Events – must be “statistically significant” to be “material” • FDA reports on pending applications – e.g., advance copy of a highly negative FDA staff report to an advisory committee • Depends on what you do with them; beware continuing to make positive statements (Zila & Zenith) • But, just because you get a bad 483 or report on a submitted study, does not mean that a prediction of approval or other statement on a product will be found to be false (Sabratek) 36

37. Life Sciences Companies Disclosures and the SEC … • Clinical Trial Results – • If disclosure involves an interpretation of the results, will only be actionable if not within the range of reasonable science • No duty to disclose all facts about a study, as long as those selected are done in a reasonable way and any omissions would not render the disclosure “so incomplete as to mislead” • Negative trial results • You have a reasonable time to evaluate – until you do, you lack “material information” • No overt duty to disclose, except if: • Your officers are trading in the stock • Public statements are misleading if the results are NOT disclosed 37

38. Life Sciences Companies Disclosures and the SEC … • Pending Investigations and Inspections – duty to disclose – company must look at to the probability and magnitude of a particular sanctions in evaluating if it’s material • Abbott Consent Decree – not material • A way to analyze – weigh: • Degree of noncompliance • Likelihood of resulting FDA action • Projected impact of such action on the company 38

39. Life Sciences Companies Disclosures and the SEC … • Recommendations – • have a prescribed process – and follow it -- for reaching internal consensus on what to publicly disclose on test results so that contrary memos don’t come back to haunt you • Define terms used to describe test results with precision – and in the disclosure document • Be very careful to not infer FDA’s conclusions on a matter – just report actions • Once you’ve made a disclosure about FDA, you have to reevaluate it as time passes and (a) either additional events occur or (b) new SEC reports are required (e.g., quarterly) 39

40. FDA-SEC Cooperation Post-Imclone • February 2004 – new ground rules on FDA interacting with SEC • FDA staff now can refer any information they may have about a suspected misstatement by an FDA-regulated public company to FDA General Counsel for review and tender to SEC • Blanket authorization for FDA staff to cooperate with SEC inquiries 40

41. Key Internal Procedures • Disclosure Committee • Executive • Financial • Legal • Other key components depending on maturity of company • Clinical or R&D • R.A. and Q.A. • Counsel – SEC, Corporate and FDA 41

42. Crisis ManagementWhat Do Vioxx and Guidant Got To Do With It?

43. A New Paradigm? … or Is Ignorance Not Bliss? … A Few Thoughts for Later • Has the bar been raised by what has been reported about corporate handling of drug and device safety? • If it has, how do you react today? • Do you have a duty to investigate even in the absence of any indicia of a problem? • Who are the enforcers – FDA or DOJ or Dr. David Franklin or Bill Lerach or Tom Pirtle? 43

44. A Few Parting Thoughts These are pictures you do not want to see …. • in your newspaper …. • on your local news …. • on the Internet …. • or • in FDA regulatory lawyers’ presentations for years to come …. 44

45. Ex-Imclone CEO Exits Federal Court After Being Charged with Nine Felony Counts 45

46. Ex-Imclone CEO exits federal court after entering guilty plea … 46

47. THE RESULT … • Pled guilty October 15, 2002 to six counts, including: • Bank fraud • Securities fraud, aka “insider trading” • Conspiracy to obstruct justice, and • Perjury • Faced: up to 65 years in prison; millions in fines 47

48. THE SENTENCE • 7- year 3-month prison sentence • with no parole • $3 million fine • $1 million in back taxes • Where can you find him now? • Schuylkill Federal Correctional Institute in Minersville, Pa. (been there since July 2003) 48

49. Let’s Go Back to My First Day at Par • Did I have a duty to disclose? • Was the information “material” • No – because it had not been investigated • Indeed – premature disclosure can harm the markets as well • Things are not always that easy 49

50. Generic Drug Scandal -- Could it happen again? • Of course – people are fallible • Your job – be prepared to be able to address if it happens on your watch • Risk Management – a key to avoiding crisis management "The price of freedom is eternal vigilance."  --  Thomas Jefferson &/or Wendell Phillips "Noncooperation with evil is as much a duty as cooperation with good." -- Gandhi 50